BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 3781730 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10097
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF NOISE WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF STORED ELECTROGRAMS. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TESTING EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE REPORTED NOISE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP, SEVERAL AUTO MODE SWITCH EPISODES WERE OBSERVED ON ATRIAL CHANNEL DUE TO NOISE. THE DEVICE WAS EXPLANTED. THERE WERE NO COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260711 ATLAS II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD V-367 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1888TC/52, BCK116916